Home / Recalls / Bien-Air Surgery Sa / Z-0176-2021

Z-0176-2021 Class II Ongoing

Recalled by Bien-Air Surgery Sa — Le Noirmont, N/A

FDA device recall Z-0176-2021 was initiated by Bien-Air Surgery Sa on September 11, 2020 and is designated Class II. Reason for recall: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. The recall status is ongoing. Affected quantity: Total US = 1120 foot pedals.

Recall Details

Product Type: Devices
Report Date: October 28, 2020
Initiation Date: September 11, 2020
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Total US = 1120 foot pedals

Product Description

Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

Reason for Recall

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

Distribution Pattern

US Nationwide distribution including in the states of CA, MI and MN.

Code Information

Model 1600407 / Catalog number 1600407-001 Serial Numbers: 16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013

Other recalls by Bien-Air Surgery Sa

Z-0180-2021 Class II — Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage (September 11, 2020)
Z-0179-2021 Class II — Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product U (September 11, 2020)
Z-0177-2021 Class II — Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Produ (September 11, 2020)
Z-0178-2021 Class II — Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usag (September 11, 2020)